LDL Liquiform. 01 English - Ref.: 111. Ref.:111. Insert. Intended use. Test principle. Methodology. Reagents Precautions and warnings
|
|
- Holly Austin
- 6 years ago
- Views:
Transcription
1 LDL Liquiform Insert Ref.:111 Intended use. System for direct homogenous determination of LDL cholesterol in serum and plasma Test principle. On the first stage of the reaction, a specific surfactant present in Reagent 1 solubilizes the chylomicrons, high-density lipoproteins (HDL), and very low-density lipoproteins (VLDL) in the sample. The solubilized cholesterol is entirely consumed by Cholesterol Esterase (CE) and Cholesterol Oxidase (CO) in a reaction that does not produce color. On the second stage, a surfactant in Reagent 2 solubilizes LDL, which is hydrolyzed by Cholesterol Esterase, yielding free cholesterol and fatty acids. Free cholesterol is oxidized by Cholesterol Oxidase to cholest-4-enone and hydrogen peroxide. Next, a coupling reaction between hydrogen peroxide, 4-aminoantipyrine and sodium disulfobutylmetatoluidine (DSBmT) is catalyzed by peroxidase, yielding a quinoneimine which has an absorbance peak at 546 nm. The resulting color intensity is directly proportional to the concentration of LDL cholesterol in the sample. First Stage CE + CO LDL + HDL + VLDL + Chylomicron + Surfactant 1 LDL + Colorless Product Second Stage Summary. LDL + Surfactant 2 CE Cholesterol + Fatty Acids CO Cholesterol + O2 Cholest-4-en-one + H2O2 Peroxidase 2 H2O 2 + DSBmT + 4-Aminoantipyrine Quinoneimine + 4 H2O The procedure for determining LDL cholesterol which combines ultracentrifugation and chemical precipitation, based on the reference method (RM) from Centers for Disease and Prevention (CDC) is time-consuming, operation-intensive, and has limited application on clinical laboratories. The LDL Liquiform system from Labtest is a liquid homogenous method for direct measurement of LDL cholesterol with a procedure that is simple and easy to perform. It is substantially equivalent to the reference method and exhibits precision and accuracy that are superior to the performance requirements established by the National Cholesterol Education Program (NCEP), in effect since The LDL Liquiform system is certified by the Cholesterol Reference Method Laboratory Network (CRMLN). The CRMLN certification program uses reference methods or indicated comparative methods that are rigorously standardized against CDC reference methods. The method specificity is achieved through the selective action of the surfactant in Reagent 1, which makes the non-ldl cholesterol consumption possible. Concentrations of triglycerides up to 1293 mg/dl, bilirubin up to 20 mg/dl, hemoglobin up to 500 mg/dl, ascorbic acid up to 50 mg/dl, and gamma globulins up to 5000 mg/dl do not interfere significantly in the reaction. The method flexibility makes the product easily applicable to automated analyzers capable of processing end-point reactions with two reagents. Methodology. Reagents 1. - Selective Surfactant. 1 Reagent 1 - Store at 2-8 ºC. Do not freeze. Reagent label bears expiration date. Contains buffer ph 6.3; cholesterol esterase <1500 U/L; cholesterol oxidase <1500 U/L; peroxidase <1300 U/L; 4-aminoantipyrine <0.1%; ascorbate oxidase <3000U/L; and surfactant <1.0% Reagent 2 - Store at 2-8 ºC. Do not freeze. Reagent label bears expiration date. Contains buffer ph 6.3; surfactant <1.0%; and DSBmT <1.0 mm Store at 2-8 ºC. Lyophilized reagent. Reagent label bears the calibrator LDL concentration and expiration date. After reconstitution, it is stable for two weeks at 2-8 ºC. Contains human LDL cholesterol and sodium azide 0.1%. Precautions and warnings For in vitro diagnostic use. Disposal of all waste material should be in accordance with local guidelines. The usual security cares should be applied to the reagent handling. The reagents must be protected from light exposure. The contains human blood derivatives and was tested for the presence of HBsAg and anti-hcv and anti-hiv antibodies with approved tests, yielding negative results for all of them. However, no known test method can offer complete assurance that human blood samples will not transmit infectious diseases. Therefore, all blood derivatives should be considered potentially infectious. The contains sodium azide as preservative. Avoid ingestion. In case of contact with eyes, immediately flush eyes with plenty of water and get medical assistance. Sodium azide may react with lead and copper plumbing and yield highly explosive metal azides. On disposal, flush with a large volume of water to prevent azide accumulation. 01 English - Ref.: 111
2 Triglycerides concentrations up to 1293 mg/dl do not interfere in LDL cholesterol results. Samples with triglycerides values >1293 mg/dl must not be diluted. Storage and stability. The Reagents 1 and 2, when stored at equipament refrigerated board, are estable up to 4 weeks. This stability time can be modified due to equipament's characteristics and maintence conditions. Therefore, its suggested to use internal quality control to monitor reagents performance. The reagents after oppened, when stored tightly closed at 2-8 ºC and when not submitted to chemical and microbial contamination, are stable up to the expiration date shown in the label. In order to avoid evaporation of the, keep the bottle tightly closed. Deterioration. reagent stability. Microbial or chemical contamination may decrease Use serum or plasma (lithium heparin and EDTA). Samples with citrate or oxalate must not be used, for they yield falsely decreased results. Serum or plasma samples may be kept at ºC for up to 14 hours. When the measurement is not to be performed within 14 hours after blood collection, samples can be stored at 2-8 ºC for 5 days and for 30 days at - 20 ºC. Samples must be stored at -80 ºC when it is necessary to preserve them for longer periods. Freeze and thaw cycles should be avoided. Thawed samples must be homogenized prior to measuring. Do not use vortex or other homogenizing device. Do not use samples with signs of microbial contamination. No known test method can offer complete assurance that human blood samples will not transmit infectious diseases. Therefore, all blood derivatives should be considered potentially infectious. Triglycerides up to 1293 mg/dl, bilirubin up to 20 mg/dl, hemoglobin up to 500 mg/dl, ascorbic acid up to 50 mg/dl, and gamma globulins up to 5000 mg/dl do not interfere significantly in the reaction. Samples with triglyceries levels above 1293 mg/dl must not be diluted. Samples with bilirubin, hemoglobin, ascorbic acid, or gamma globulins levels above the ones previously referred must be diluted with NaCl 150 mmol/l (0.85%) before performing the tests, and the results obtained must be multiplied by the dilution factor. Materials required not provided Specimen collection and preparation Interference A constant temperature water bath (37 ºC). Photometer capable of measuring absorbance at nm. Pipets to measure reagents and samples. Timer. Preparing the calibrator. Add 1.0 ml of deionized or distilled water to the vial. Let it stand for 5 minutes. Mix gently by inversion, avoiding the formation of foam. It is stable for 2 weeks at 2-8 ºC, in a tightly shut vial to avoid evaporation. Manual procedure This procedure is not applicable to semi-automatic analyzers that use flow cells exclusively. Set up two tubes and proceed as follows: Sample Reagent 1 Mix and incubate in a water bath at 37 ºC for 5 minutes. Measure the A absorbance of the Unknown and against water at 546 nm ( ). Reagent 2 Mix and incubate at 37 ºC for 5 minutes. Measure the A2 absorbance of the Unknown and against water at 546 nm ( ). The color is stable for 15 minutes. Calibration. Quality control. Calculations. The calibrator is traceable to CDC reference method. Manual calibrations Perform a new calibration after reagent lot change or when the internal quality control indicates. Automatic Systems Blank of reagents: water or 0.85% NaCl; Standards: use the from the product. Calibration frequency Two point calibration after reagent lot change; Two point calibration when the internal quality control indicates. For quality control use Qualitrol H Level 1 and Qualitrol H Level 2 or other suitable control material. The limits and control interval must be adapted to the laboratory requirements. Each laboratory should establish corrective actions to be taken if values fall outside the control limits. The first absorbance measurement (A ) must be corrected to the final volume of the reaction (A LDL concentration. A = A x cor 1 LDL (mg/dl) = Unknown 0.01 ml 0.75 ml Unknown (A - A ) (A - A ) x C 1cor 0.01 ml 0.75 ml 0.25 ml 0.25 ml 1 ) before calculating the 1 02 English - Ref.: 111
3 Due to the high reproducibility of the method, the LDL concentration can be calculated using the factor method. FACTOR = C (A - A ) LDL (mg/dl) = Unknown (A - A ) x Factor Analytical measurement range. The rate of the reaction is linear between 6.6 and 992 mg/dl. Samples with LDL concentrations higher than 992 mg/dl must be diluted with NaCl 150 mmol/l (0.85%). Perform a new LDL test with the diluted sample and multiply the result by the dilution factor. Expected range. The following reference values were determined using statistically treated epidemiologic data, and they correlate cholesterol levels to coronary artery disease (CAD) prevalence. ATP III Cholesterol Guidelines - Total Cholesterol, LDL, and HDL (mg/dl) HDL Cholesterol (mg/dl) Children and Teenagers 4 Age: <10 years old Age: years old Conversion: Conventional units (mg/dl) x = SI Units (mmol/l) Performance characteristics Recovery studies. In two samples with LDL concentrations of 55.2 mg/dl and 41.5 mg/dl different quantities of LDL were added. Subsequent analyses provided recoveries ranging from 98 to 101.7%. The mean proportional systematic error was mg/dl at 130 mg/dl, and mg/dl at 160 mg/dl Method comparison A group of 54 samples were assayed by the proposed method and the ultracentrifugation method. The comparisons yielded a correlation coefficient of and the regression equation was y = 0.96x Total Cholesterol Borderline Adults 3 < Imprecision - Within run Sample 1 Sample 2 Sample 3 N Mean (mg/dl) SD (mg/dl) %CV LDL Cholesterol HDL Cholesterol Optimal Near Optimal Borderline Very Low (desirable) Adults 3 Adults 3 < <40 60 Imprecision - Run-to-run Sample 1 Sample 2 Sample 3 N Analytical sensitivity. Mean (U/L) SD (U/L) %CV Detection limit: mg/dl. The detection limit represents the lowest measurable LDL concentration that can be distinguished from zero. It is calculated as two standard deviations from the mean of 20 replicates of one sample without LDL. Total Cholesterol (mg/dl) Children and Teenagers 4 Age: 2-19 years old Borderline LDL Cholesterol (mg/dl) Children and Teenagers 4 Age: 2-19 years old Borderline < < Notes 1. The material cleaning and drying are fundamental factors to the reagent stability and to obtain correct results. 2. The deionized or distilled water in the laboratory to prepare reagents, use in the measurements and for final glass washing must have resistivity 1 megaohm.cm, or conductivity 1 microsiems/cm and silicates concentration must be <0.1mg/L. 03 English - Ref.: 111
4 3. It is suggested to consult to review physiopathological sources and drug interferences in results and methodologies. References 1. Bachorik PS, Ross JW. Clin Chem 1995;41: Westgard JO, Barry PL, Hunt MR, Groth T. Clin Chem 1981; 27: Executive Summary of the Third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA 2001;285: Leite PF, Martinez TLR, Halpern A, Cendoroglo MS, Novazzi JP, Fonseca FAH, Dias JCA. Risco cardiovascular: fatores metabólicos e nutricionais: diagnóstico e tratamento. São Paulo: Loyola, p Labtest: Data on File. Presentation Application procedures using LDL Liquiform are available for various automated systems. The number of tests in automated systems depends on the programmed parameters. Consumer information [Warranty conditions] Labtest Diagnóstica warrants the performance of this product under the specifications until the expiration date shown in the label provided that the procedures and storage conditions indicated on the label and in this insert have been followed correctly. Labtest Diagnóstica S.A. CNPJ: / Av. Paulo Ferreira da Costa, Vista Alegre - CEP Lagoa Santa. Minas Gerais Brasil - Consumer Service sac@labtest.com.br Product LDL Liquiform Reference 111-1/ Contents 1 X 30 ml 1 X 10 ml 1 X 1,0 ml Revision: July, 2011 Ref.: Copyright by Labtest Diagnóstica S.A. Reproduction under previous autorization 04 English - Ref.: 111
5 05 English - Ref.: 111
6 Símbolos utilizados com produtos diagnósticos in vitro Símbolos usados con productos diagnósticos in vitro Symbols used with ivd devices Conteúdo suficiente para < n > testes Contenido suficiente para < n > tests Contains sufficient for < n > tests Risco biológico Riesgo biológico Biological risk Data limite de utilização (aaaa-mm-dd ou mm/aaaa) Estable hasta (aaaa-mm-dd o mm/aaaa) Use by (yyyy-mm-dd or mm/yyyy) Marca CE Marcado CE CE Mark Material Tóxico Tóxico Poison Material Reagente Reactivo Reagent Limite de temperatura (conservar a) Temperatura limite (conservar a) Temperature limitation (store at) Fabricado por Elaborado por Manufactured by Representante Autorizado na Comunidade Europeia Representante autorizado en la Comunidad Europea Authorized Representative in the European Community Número do lote Denominación de lote Batch code Consultar instruções de uso Consultar instrucciones de uso Consult instructions for use e Número do catálogo Número de catálogo Catalog Number e negativo negativo Negative control Adições ou alterações significativas Cambios o suplementos significativos Significant additions or changes e positivo positivo Positive control Produto diagnóstico in vitro Dispositivo de diagnóstico in vitro In vitro diagnostic device e Liofilizado Liofilizado Lyophilized Corrosivo Corrosivo Corrosive Período após abertura Período post-abertura Period after-opening Ref.: English - Ref.: 111
HDL LE. 01 Inglês - Ref.: 98. Ref.:98. Insert. Methodology. Intended use. Reagents. Test principle Precautions and warnings. Summary.
HDL LE Insert Ref.:98 Intended use. For the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum and plasma. Test principle. This method is based on accelerating the reaction
More information1. Reagent Store at 2-8 ºC.
LDL Insert Ref.:146 Intended use. System for direct quantitative determination of low density lipoprotein (LDL) in serum or plasma samples. Professional use. [For in vitro diagnostic use.] Test principle.
More informationHDL LE Insert. 01 English - Ref.: 98. Ref.:98
HDL LE Insert Ref.:98 Intended use. For the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum and plasma. Professional use. [For in vitro diagnostic use.] Test principle.
More informationLDL LD. 01 English - Ref.: 129. Ref.:129. Insert. Intended use. Methodology. Reagents. Test principle. Summary. Precautions and warnings
LDL LD Insert Ref.:129 Intended use. System for direct quantitative determination of low density lipoprotein (LDL) in serum or plasma samples. [For in vitro diagnostic use.] Test principle. The method
More informationHDL CHOLESTEROL. 01 English - Ref.: 13. Ref.:13. Insert
HDL CHOLESTEROL Insert Ref.:13 Intended use. System for selective precipitation of Low and Very Low Density Lipoproteins (LDL and VLDL) and HDL cholesterol measurement in the supernatant, by an end point
More informationENZYMATIC CREATININE Insert
ENZYMATIC CREATININE Insert Ref.:17 Intended use. System for determination of creatinine in serum, plasma, and urine samples by end-point reaction. Professional use. [ Only for in vitro diagnostic use.]
More informationUREA CE Insert. 01 English - Ref.: 27. Ref.:27
UREA CE Insert Ref.:27 Intended use. Colorimetric and enzymatic system for urea determination in samples of blood and urine, by end point reaction. Professional use. [Only for in vitro diagnostic use.]
More informationAPTT HEMOSTASIS Insert
APTT HEMOSTASIS Insert Ref.:502 Activated Partial Thromboplastin Time Intended use. System for determination of activated partial thromboplastin time (APTT) and measurement of coagulation factors based
More informationGLUCOSE GOD. 01 English - Ref.: 134. Ref.:134. Insert
GLUCOSE GOD Insert Ref.:134 Intended use. Enzymatic system for the determination of glucose in blood, cerebrospinal, ascitic, pleural and synovial fluids by kinetic method. [ Use only for in vitro diagnosis.
More informationQUALITROL 2H Insert. 01 Inglês - Ref.: 72. Ref.:72. Precautions and warnings
QUALITROL 2H Insert Ref.:72 Lot 6002 Expiration 2019/08/23 Precautions and warnings Qualitrol 2H is for in vitro diagnostic use only. Attention. It is suggested to verify carefully if the lot number pressed
More informationGLUCOSE Liquiform. 01 English - Ref.: 133. Ref.:133. Insert. Intended use. Methodology. Reagents. Principle Precautions and warnings. Summary.
GLUCOSE Liquiform Insert Ref.:133 Intended use. Enzymatic system for the determination of glucose in blood, cerebrospinal, ascitic, pleural and synovial fluids by kinetic or endpoint method. [Use only
More informationTSH. 01 English - Ref.: 903. Ref.:903. Insert. Intended use. System for quantitative determination of the thyroid stimulating hormone (TSH) in serum.
TSH Insert Intended use. System for quantitative determination of the thyroid stimulating hormone (TSH) in serum. [Only for in vitro diagnostic use.] Test principle. The TSH present in the sample is specifically
More information1. Calibra - H - Store at 2-8 ºC.
CALIBRA H Insert Ref.:80 Lot Expiration Calibrator Attention. It is suggested to verify carefully if the lot number printed in this insert corresponds to the lot on the bottle label. Intended use. is a
More informationTNF-alpha ELISA. For Research Use Only. Not For Use In Diagnostic Procedures.
TNF-alpha ELISA For the quantitative determination of TNF-alpha in serum, plasma, buffered solution or cell culture medium. For Research Use Only. Not For Use In Diagnostic Procedures. Catalog Number:
More informationhcg 01 English - Ref.: 904 Ref.:904 Insert Intended use. System for quantitative determination of Human Chorionic Gonadotropin - hcg in serum.
hcg Insert Ref.:904 Intended use. System for quantitative determination of Human Chorionic Gonadotropin - hcg in serum. [Only for in vitro diagnostic use.] Introduction 1. The hcg molecule is comprised
More informationBCH 447. Triglyceride Determination in Serum
BCH 447 Triglyceride Determination in Serum Introduction: Triglycerides are esters of fatty acids and are hydrolyzed by lipase to glycerol and free fatty acids. Triglyceride determinations when performed
More informationInsulin ELISA. For the quantitative determination of insulin in serum and plasma.
Insulin ELISA For the quantitative determination of insulin in serum and plasma. For In Vitro Diagnostic use within the United States of America. This product is for Research Use Only outside of the United
More informationRat Hemoglobin A1c (HbA1c) Kit Instructions
V.3 Crystal Chem Rat Hemoglobin A1c (HbA1c) Kit Instructions For the quantitative determination of hemoglobin A1c (HbA1c) in rat whole blood Catalog #80300 96 Assays For research use only. Not for use
More informationTriglyceride determination
Triglyceride determination Introduction: - Triglycerides are esters of fatty acids and are hydrolyzed to glycerol and free fatty acids (by lipase) - Triglyceride determinations when performed in conjunction
More information1 Introduction Imprecision Within-run imprecision, results Day-to-day imprecision, results... 2
Design Verification liquicolor 1 Introduction... 2 2 Imprecision... 2 2.1 Within-run imprecision, results... 2 2.2 Day-to-day imprecision, results... 2 3 Linearity and Detection Limit... 2 3.1 Linearity...
More informationClinical Chemistry (CHE 221)
Clinical Chemistry (CHE 221) Experiment # 14 Blood Alcohol Determination by Gas Chromatography and by Reaction with Alcohol Dehydrogenase Name Date Performed Date Submitted Partners Name(s) Partners Name(s)
More informationInsulin ELISA. For the quantitative determination of insulin in serum and plasma
Insulin ELISA For the quantitative determination of insulin in serum and plasma For In Vitro Diagnostic use within the United States of America. This product is for Research Use Only outside of the United
More informationAPOB (Human) ELISA Kit
APOB (Human) ELISA Kit Catalog Number KA4330 96 assays Version: 01 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle of the Assay...
More informationApolipoprotein A-1 ELISA
Apolipoprotein A-1 ELISA For the quantitative determination of apolipoprotein A1 in serum and plasma. For Research Use Only. Not For Use In Diagnostic Procedures. Please read carefully due to Critical
More informationInfluenza A IgG ELISA
Influenza A IgG ELISA For the qualitative determination of IgG-class antibodies against Influenza A virus in human serum or plasma (citrate, heparin). For Research Use Only. Not For Use In Diagnostic Procedures.
More informationFor In Vitro Diagnostic Use. Rx Only. Reviewed by Date Reviewed by Date
SYNCHRON System(s) Chemistry Information Sheet 2015 Beckman Coulter, Inc. All rights reserved. HDLD HDL Cholesterol 650207 For In Vitro Diagnostic Use ANNUAL REVIEW Rx Only Reviewed by Date Reviewed by
More informationHBeAg and HBeAg Ab ELISA Kit
HBeAg and HBeAg Ab ELISA Kit Catalog Number KA0290 96 assays Version: 17 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Principle of the Assay... 3
More informationBovine Insulin ELISA
Bovine Insulin ELISA For quantitative determination of insulin in bovine serum and plasma. For Research Use Only. Not For Use In Diagnostic Procedures. Catalog Number: 80-INSBO-E01 Size: 96 wells Version:
More informationHbA1c (Human) ELISA Kit
HbA1c (Human) ELISA Kit Cat. No.:DEIA3509 Pkg.Size:96T Intended use GHbA1c (Human) ELISA Kit is a sandwich enzyme immunoassay for the quantitative measurement of human GHbA1c. General Description vhemoglobin,
More informationEliKine Free Thyroxine (ft4) ELISA Kit
EliKine Free Thyroxine (ft4) ELISA Kit Booklet Item NO. KET0005 Product Name EliKine Free Thyroxine (ft4) ELISA Kit ATTENTION For laboratory research use only. Not for clinical or diagnostic use TABLE
More informationPorcine/Canine Insulin ELISA
Porcine/Canine Insulin ELISA For the quantitative determination of insulin in porcine or canine serum and plasma. Please read carefully due to Critical Changes, e.g., Calculation of Results. For Research
More informationRat Insulin ELISA. For the quantitative determination of insulin in rat serum and plasma. For Research Use Only. Not For Use In Diagnostic Procedures.
Rat Insulin ELISA For the quantitative determination of insulin in rat serum and plasma For Research Use Only. Not For Use In Diagnostic Procedures. Catalog Number: Size: 80-INSRT-E01, E10 96 wells, 10
More informationTSH Receptor Autoantibody ELISA
Li StarFish S.r.l. Via Cavour, 35-20063 Cernusco S/N (MI), Italy Tel. +39-02-92150794 - Fax. +39-02-92157285 info@listarfish.it -www.listarfish.it TSH Receptor Autoantibody ELISA Product Data Sheet Cat.
More informationMouse C-Peptide ELISA Kit
Mouse C-Peptide ELISA Kit Cat.No: DEIA4507 Lot. No. (See product label) Size 96T Intended Use The Mouse C-Peptide ELISA kit is for the quantitative determination of c-peptide in mouse serum, plasma, and
More informationInsulin (Porcine/Canine) ELISA
Insulin (Porcine/Canine) ELISA For the quantitative measurement of insulin in Porcine/Canine serum and plasma (EDTA) For Research Use Only. Not For Use In Diagnostic Procedures. Catalog Number: 80-INSPO-E01
More informationH.Pylori IgG
DIAGNOSTIC AUTOMATION, INC. 21250 Califa Street, Suite 102 and116, Woodland Hills, CA 91367 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com
More informationH.Pylori IgG Cat # 1503Z
DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external
More information02006B 1 vial 02006B 1 vial Store at -20 C. Lyophilized recombinant IL-2
For detection and measurement of human interleukin 2 Catalog #02006 Catalog #02007 2 Plates 10 Plates Product Description The Human Interleukin 2 (IL-2) ELISA Kit is designed for the quantitative detection
More informationRat C-peptide ELISA. For the quantitative determination of C-peptide in rat serum
Rat C-peptide ELISA For the quantitative determination of C-peptide in rat serum Please read carefully due to Critical Changes, e.g., see Calculation of Results. For Research Use Only. Not For Use In Diagnostic
More informationRubella virus IgG ELISA Kit
Rubella virus IgG ELISA Kit Catalog Number KA0223 96 assays Version: 03 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle of
More informationFor in vitro diagnostic use only. For Rx use only. Reviewed by Date Reviewed by Date
AU US Instructions For Use 2018 Beckman Coulter, Inc. All rights reserved. TRIG TRIGLYCERIDE OSR60118 4 x 20 ml R1, 4 x 5 ml R2 OSR61118 4 x 50 ml R1, 4 x 12.5 ml R2 OSR66118 4 x 173 ml R1, 4 x 48 ml R2
More informationHuman Thyroid-Peroxidase Antibody, TPO-Ab ELISA Kit
Human Thyroid-Peroxidase Antibody, TPO-Ab ELISA Kit Catalog No: E0442h 96 Tests Operating instruction www.eiaab.com FOR RESEARCH USE ONLY; NOT FOR THERAPEUTIC OR DIAGNOSTIC APPLICATIONS! PLEASE READ THROUGH
More informationHerpes Simplex Virus 2 IgM HSV 2 IgM
DIAGNOSTIC AUTOMATION, INC. 21250 Califa Street, Suite 102 and 116, Woodland Hills, CA 91367 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com
More informationSee external label 2 C-8 C 96 tests Chemiluminescence. CMV IgM. Cat # Diluted samples, controls & calibrator 100 µl 30 minutes
DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external
More informationELEGANCE Chlamydia pneumoniae IgG ELISA KIT
INTENDED USE The ELEGANCE Chlamydia pneumoniae IgG ELISA has been designed for the in vitro diagnostic measurement of anti- Chlamydia pneumoniae IgG in the screening of human serum. PRINCIPLES OF THE ELEGANCE
More informationLDL (Human) ELISA Kit
LDL (Human) ELISA Kit Cat. No.:DEIA3864 Pkg.Size:96T Intended use This immunoassay kit allows for the specific measurement of human low density lipoprotein, LDL concentrations in cell culture supernates,
More informationRat cholesterol ELISA Kit
Rat cholesterol ELISA Kit Catalog No. CSB-E11706r (96T) This immunoassay kit allows for the in vitro quantitative determination of rat Cholesterol concentrations in serum, plasma and other biological fluids.
More informationProcine sphingomyelin ELISA Kit
Procine sphingomyelin ELISA Kit For the quantitative in vitro determination of Procine sphingomyelin concentrations in serum - plasma - celiac fluid - tissue homogenate - body fluid FOR LABORATORY RESEARCH
More informationMouse C-peptide ELISA
Mouse C-peptide ELISA For the quantitative determination of C-peptide in mouse serum. For Research Use Only. Not for use in Diagnostic Procedures. Please read carefully due to Critical Changes, e.g., Calculation
More informationDIAGNOSTIC AUTOMATION, INC.
DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external
More informationHigh-density Lipoprotein Cholesterol (HDL-C) Assay Kit
(FOR RESEARCH USE ONLY. DO NOT USE IT IN CLINICAL DIAGNOSIS!) High-density Lipoprotein Cholesterol (HDL-C) Assay Kit (Double reagents) Catalog No: E-BC-K221 Method: Colorimetric method Specification: 96T
More informationH. pylori IgM. Cat # H. pylori IgM ELISA. ELISA: Enzyme Linked Immunosorbent Assay. ELISA - Indirect; Antigen Coated Plate
DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com H. pylori
More informationVedolizumab Drug Level ELISA
Vedolizumab Drug Level ELISA For the quantitative determination of free Entyvio concentration in human serum and EDTA plasma. Please read carefully due to Critical Changes, e.g., Updates to specificity
More informationGLUCOSE LIQUIFORM VET
GLUCOSE LIQUIFORM VET Insert Ref.:1012 Intended use. Enzymatic system for the determination of glucose in blood, cerebrospinal, ascitic, pleural and synovial fluids by kinetic or endpoint method. [Use
More informationInstructions for use. TSH rat ELISA. Please use only the valid version of the Instructions for Use provided with the kit AR E-8600
Instructions for use TSH rat ELISA AR E-8600 TSH rat ELISA 1. INTRODUCTION 1.1 Intended use The TSH rat ELISA is an enzyme immunoassay for the quantitative measurement of TSH in rat serum. For research
More informationMouse C-peptide ELISA
Mouse C-peptide ELISA For the quantitative determination of C-peptide in mouse serum. For Research Use Only. Not for use in Diagnostic Procedures. Please read carefully due to Critical Changes, e.g., Preparation
More informationThis package insert contains information to run the Cholesterol assay on the ARCHITECT c Systems.
en CHOLESTEROL 7D62 304796/R02 CHOLESTEROL This package insert contains information to run the Cholesterol assay on the ARCHITECT c Systems. Read Highlighted Changes Revised October 2012 Package insert
More informationHuman Cytomegalovirus IgM ELISA Kit
Human Cytomegalovirus IgM Catalog No: IRAPKT2012 ELISA Kit Lot No: SAMPLE INTENDED USE The CMV IgM ELISA is intended for use in the detection of IgM antibodies to Cytomegalovirus (CMV) infection in human
More informationSerum Amyloid A ELISA
Serum Amyloid A ELISA For the quantitative determination of serum amyloid A (SAA) in serum plasma For Research use Only. Not for Use in Diagnostic Procedures Please see Appendix A for Reference Serum information
More informationMouse Ultrasensitive Insulin ELISA
Mouse Ultrasensitive Insulin ELISA For the quantitative determination of insulin in mouse serum and plasma. Please read carefully due to Critical Changes, e.g., Calculation of Results. For Research Use
More informationSee external label 96 tests HSV 2 IgA. Cat #
DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external
More informationIV2-113E Use by. Invitron Glargine ELISA Kit REF LOT IVD. Definitions. English. For in-vitro diagnostic use. Instructions for use.
Definitions Instructions for use REF Catalogue number IV2-113E Use by English Invitron Glargine ELISA Kit For in-vitro diagnostic use Σ 96 LOT IVD Lot/Batch Code Storage temperature limitations In vitro
More informationRat C-peptide ELISA. For the quantitative determination of C-peptide in rat serum. For Research Use Only. Not For Use In Diagnostic Procedures.
Rat C-peptide ELISA For the quantitative determination of C-peptide in rat serum. For Research Use Only. Not For Use In Diagnostic Procedures. Catalog Number: Size: 80-CPTRT-E01 96 wells Version: May 26,
More informationHelicobacter pylori IgA ELISA Kit
Helicobacter pylori IgA ELISA Kit Catalog Number KA0964 96 assays Version: 03 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle
More informationCYTOMEGALOVIRUS (CMV) IgM ELISA Kit Protocol
CYTOMEGALOVIRUS (CMV) IgM ELISA Kit Protocol (Cat. No.:EK-310-91) 330 Beach Road, Burlingame CA Tel: 650-558-8898 Fax: 650-558-1686 E-Mail: info@phoenixpeptide.com www.phoenixpeptide.com INTENDED USE The
More informationTSH ELISA Kit Medical Device Licence No.: 16419
TSH ELISA Kit Medical Device Licence No.: 16419 Enzyme immunoassay kit for the quantitative determination of TSH concentration in serum. Catalog Number: SL100305 Catalog Number: SL100306 Catalog Number:
More informationToxoplasma gondii IgM ELISA Kit
Toxoplasma gondii IgM ELISA Kit Catalog Number KA0226 96 assays Version: 02 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle
More informationToxoplasma gondii IgM ELISA Kit
Toxoplasma gondii IgM ELISA Kit Catalog Number KA0226 96 assays Version: 01 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle
More informationCanine Thyroid Stimulating Hormone, TSH ELISA Kit
Canine Thyroid Stimulating Hormone, TSH ELISA Kit Catalog No: E0463c 96 Tests Operating instruction www.eiaab.com FOR RESEARCH USE ONLY; NOT FOR THERAPEUTIC OR DIAGNOSTIC APPLICATIONS! PLEASE READ THROUGH
More informationToxoplasma gondii IgM (Toxo IgM)
DIAGNOSTIC AUTOMATION, INC. 21250 Califa Street, Suite 102 and116, Woodland Hills, CA 91367 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com
More informationH. pylori IgM CLIA kit
H. pylori IgM CLIA kit Cat. No.:DEEL0251 Pkg.Size:96 tests Intended use Helicobacter pylori IgM Chemiluminescence ELISA is intended for use in evaluating the serologic status to H. pylori infection in
More informationHerpes Simplex Virus 2 IgG HSV 2 IgG
DIAGNOSTIC AUTOMATION, INC. 21250 Califa Street, Suite 102 and 116, Woodland Hills, CA 91367 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com
More informationSIV p27 Antigen ELISA Catalog Number:
INTENDED USE The RETRO-TEK SIV p27 Antigen ELISA is for research use only and is not intended for in vitro diagnostic use. The RETRO-TEK SIV p27 Antigen ELISA is an enzyme linked immunoassay used to detect
More informationINSTRUCTIONS FOR USE
VITROS Chemistry Products Reagent 680 1728 Rx ONLY Intended Use For in vitro diagnostic use only. VITROS Chemistry Products Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry
More informationVGKC-Autoantibody Assay RIA
Instructions for Use VGKC-Autoantibody Assay RIA 125I-Radio Immuno Assay for the Quantitative Determination of Antibodies to the Voltage-Gated Potassium Channel (VGKC) in Serum I V D REF RA115/25 25 2
More informationTechnical Bulletin. Cholesterol Reference Method Laboratory Network (CRMLN) Overview. TB Rev. 0
Technical Bulletin Reference Method Laboratory Network (CRMLN) Overview TB000020 Rev. 0 Reference Method Laboratory Network (CRMLN) - General Information With guidance from the US Centers for Disease Control
More informationH.Pylori IgM Cat # 1504Z
DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external
More informationSee external label 2 C-8 C Σ=96 tests Cat # 1505Z. MICROWELL ELISA H.Pylori IgA Cat # 1505Z
DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external
More informationH.pylori IgA Cat #
DIAGNOSTIC AUTOMATION, INC. 23961 Craftsman Road, Suite D/E/F, Calabasas, CA 91302 Tel: (818) 591-3030 Fax: (818) 591-8383 onestep@rapidtest.com technicalsupport@rapidtest.com www.rapidtest.com See external
More informationTABLE OF CONTENTS GENERAL INFORMATION... 1
BIOO RESEARCH PRODUCTS Glucose Assay Kit Manual Catalog #: 5611-01 BIOO Scientific Corp. 2011 TABLE OF CONTENTS GENERAL INFORMATION... 1 Product Description... 1 Procedure Overview... 1 Required Materials
More informationFinTest IgG4 Screen 20 ELISA KIT
FinTest IgG4 Screen 20 ELISA KIT Cat. No.:DEIA6196 Pkg.Size:96T Intended use Enzyme immunoassay (microtiter strips) for the detection and the quantitative determination of IgG4 antibodies against 20 Food
More informationAnthrax protective antigen IgG ELISA Kit
Anthrax protective antigen IgG ELISA Kit Catalog Number KA0953 96 assays Version: 04 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3
More informationFinTest TM IgG4 Screen 88 ELISA Kit
FinTest TM IgG4 Screen 88 ELISA Kit Cat. No.:DEIA6227 Pkg.Size:96T Intended use The Kit is for the quantitative determination of IgG4 antibodies against 88 Food Allergens in human serum, plasma and capillary
More informationCotinine (Mouse/Rat) ELISA Kit
Cotinine (Mouse/Rat) ELISA Kit Catalog Number KA2264 96 assays Version: 03 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle
More informationRat Proinsulin ELISA
Rat Proinsulin ELISA For the quantitative determination of proinsulin in rat serum For Research Use Only. Not For Use In Diagnostic Procedures. Catalog Number: 80-PINRT-E01 Size: 96 wells Version: June
More informationHuman HIV (1+2) antigen&antibody ELISA Kit
Human HIV (1+2) antigen&antibody ELISA Kit Catalog Number. CSB-E18042h For the qualitative determination of human HIV (1+2) antibody and P24 antigen concentrations in serum, plasma. This package insert
More informationCortisol (Sheep) ELISA Kit
Cortisol (Sheep) ELISA Kit Catalog Number KA0919 96 assays Version: 03 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle of the
More informationMouse C3 (Complement Factor 3) ELISA Kit
Mouse C3 (Complement Factor 3) ELISA Kit Cat. No.:DEIA8289 Pkg.Size:96T Intended use The Mouse C3 (Complement Factor 3) ELISA Kit is a highly sensitive two-site enzyme linked immunoassay (ELISA) for measuring
More informationHuman Cytomegalovirus Virus (CMV) IgG ELISA Kit
Human Cytomegalovirus Virus Catalog No: IRAPKT1410 (CMV) IgG ELISA Kit Lot No: SAMPLE INTENDED USE The CMV IgG ELISA is intended for use in evaluating a patient s serologic status to cytomegalovirus (CMV)
More informationMyeloperoxidase (MPO) ELISA Stool, Urine KIT
Myeloperoxidase (MPO) ELISA Stool, Urine KIT Cat. No.:DEIA6211 Pkg.Size:96T Intended use The Myeloperoxidase Assay is intended for the quantitative determination of Myeloperoxidase in urine and stool,
More informationMorinaga Mouse C-peptide ELISA Kit
Morinaga Mouse C-peptide ELISA Kit For the quantitative determination of C-peptide in mouse serum, plasma, and fluid 96wells For Laboratory Use Only, not for use in diagnostic procedure Please read full
More informationRat Mullerian Inhibiting Substance/Anti-Mullerian hormone, MIS/AMH ELISA kit
Rat Mullerian Inhibiting Substance/Anti-Mullerian hormone, MIS/AMH ELISA kit Catalog No. E0228r (96 tests) Operating instruction www.eiaab.com FOR RESEARCH USE ONLY; NOT FOR THERAPEUTIC OR DIAGNOSTIC APPLICATIONS!
More informationTriiodothyronine (T3) ELISA
For Research Use Only. Not for use in Diagnostic Procedures. INTENDED USE The GenWay, Inc. Triiodothyronine (T3) ELISA Kit is intended for the detection of total T3 in human serum or plasma. For research
More informationFor In Vitro Diagnostic Use
SYNCHRON System(s) Chemistry Information Sheet Lactate REF A95550 For In Vitro Diagnostic Use ANNUAL REVIEW Refer to Review and Revision Coversheet at the front of each method. PRINCIPLE INTENDED USE reagent,
More information3 Linearity and Detection Limit Linearity Detection limit... 4
Design Verification liquicolor 1 Introduction... 2 2 Imprecision, Reproducibility... 2 2.1 Data from internal study... 2 2.2 Date from external study (Cholesterol Reference Method Laboratory Network)...
More informationHuman Hemoglobin Colorimetric Detection Kit
Human Hemoglobin Colorimetric Detection Kit CATALOG NO: IRAAKT2522 LOT NO: SAMPLE INTENDED USE The Hemoglobin detection kit is designed to quantitatively measure all forms of hemoglobin present in blood
More informationUltra-sensitive Human TSH ELISA Kit. MyBioSource.com
Ultra-sensitive Human TSH ELISA Kit For the quantitative determination of human thyroid stimulating hormone (TSH) concentrations in serum Catalog Number: MBS590037 96 tests FOR LABORATORY RESEARCH USE
More informationMouse Leptin ELISA Kit Instructions
V.6/Mar/2008 CRYSTAL CHEM INC. Mouse Leptin ELISA Kit Instructions For the quantitative determination of leptin in mouse serum or plasma and fluid Catalog #: 90030 96 Assays For Research Use Only. Not
More informationH. pylori Antigen ELISA Kit
H. pylori Antigen ELISA Kit Catalog Number KA3142 96 assays Version: 04 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Intended Use... 3 Background... 3 Principle of
More informationCoQ10(Coenzyme Q10) ELISA Kit
CoQ10(Coenzyme Q10) ELISA Kit Catalogue No.: EU0196 Size: 48T/96T Reactivity: Universal Detection Range: 0.781-50ng/ml Sensitivity:
More information